Committee publications
Xenotransplantation and the law: Mexico as a case study on regulatory barriers
This article analyses xenotransplantation from a global perspective, highlighting the relevant technological drivers, ethical debates, regulatory frameworks and clinical milestones. Additionally, this article uses Mexico’s legal framework as a practical case study, showing how existing health laws can inadvertently create barriers to interspecies organ transplantation (animal to human), even though the laws themselves do not explicitly prohibit it.
Released on Dec 4, 2025
Regulatory evolution of medicinal cannabis and the new legal framework for hemp in cosmetic and food applications in Peru
Peru’s regulatory landscape for cannabis and hemp is evolving rapidly. The country has made considerable progress in the development of marketing authorisation categories and compounding, facilitating access to medicinal cannabis. The recent enactment of Law No. 32195 introduces a legal framework for industrial hemp, paving the way for its use in cosmetics and food. This article explores the positive regulatory developments and the anticipated impact of the upcoming regulation, highlighting Peru’s alignment with international standards and its potential for industrial innovation.
Released on Dec 4, 2025
Regulatory challenges to the treatment of rare and orphan diseases
This article analyses the regulatory challenges faced in regard to the treatment of rare and orphan diseases in Peru, highlighting recent legal advances, such as the enactment of Law No. 29698, its regulatory framework and Law No. 32319. Key issues involving the new accelerated procedure for the sanitary registration of products for the treatment of rare diseases are examined, as well as challenges related to financing, research and data management. The implementation of certain mechanisms, such as the reliance model adopted by the General Directorate of Medicines, Supplies and Drugs (La Dirección General de Medicamentos, Insumos y drogas or DIGEMID), is emphasised as a strategic step towards improving patient access to high-cost treatments and strengthening regulatory efficiency.
Released on Dec 4, 2025
Environmental sustainability and ESG compliance in the life sciences industry
Sustainability laws affect businesses across the life sciences sector, from medical devices, pharmaceuticals and cosmetics to food and chemicals. In this article, we outline five key areas of regulation affecting the industry and provide some practical tips for companies to adopt as they prepare for compliance.
Released on Dec 4, 2025
Medical cannabis in Paraguay: regulatory framework and development opportunities
The use of cannabis for medicinal purposes in Paraguay is regulated by a specific legal framework that seeks to ensure both the promotion of scientific research and access to treatment for patients in need. Law No. 6007/2017 establishes the national programme for medical and scientific study and research on the medicinal use of the cannabis plant and its derivatives (Que crea El Programa Nacional para el Estudio y la Investigación Médica y Científica del uso Medicinal de la Planta de CANNABIS y sus Derivados or PROINCUMEC), which is subject to administration by the National Health Surveillance Directorate (Dirección Nacional de Vigilancia Sanitaria or DINAVISA) and the supervision of the National Anti-Drug Secretariat (Secretaría Nacional Antidrogas or SENAD).
Released on Dec 4, 2025
Digital accessibility in favour of disabled people in France: years of legislative efforts now enhanced by the transposition of Directive (EU) 2019/882 (EAA)
Digital accessibility in favour of disabled persons remains a major challenge despite 20 years of legislative efforts. In France, the 2005 Disability Act imposes obligations on the public and assimilated sector as well as certain large private companies, while Directive (EU) 2019/882, applicable since 28 June 2025 and now transposed into French law, establishes a separate regime for private actors, targeting in particular e-commerce, payment terminals and transport services. This article sheds light on the relationship between the two sets of regulation and asks: is the EAA an additional constraint or is this combination of rules a strategic lever?
Released on Dec 4, 2025
Pharmaceutical advertising in Brazil: regulatory framework, social media and associated debates
The growing influence of social media marketing has reshaped how pharmaceutical products are promoted, challenging existing regulatory models. This article examines Brazil’s legal and regulatory framework for pharmaceutical advertising, highlighting how digital platforms and influencer culture circumvent traditional rules and increase the risks of misinformation and self-medication. It explores tensions between consumer rights, freedom of expression and public health protection by analysing Brazilian law, ANVISA’s Resolution No 96/2008 and recent judicial developments such as the ADI 7,788 case. Comparative perspectives from the United States and the European Union help contextualise Brazil’s precautionary approach to regulating pharmaceutical communication in the digital era.
Released on Dec 4, 2025
Managing drug stocks: current issues in France and challenges at European level
Drug shortages are becoming increasingly frequent, due to multiple factors. At French and European levels, regulations have been strengthened and impose more obligations on pharmaceutical companies. While patient protection and treatment availability are indisputable priorities, the obligations imposed on manufacturers must remain proportionate and compatible with economic, logistical and technical realities. Indeed, the response cannot be limited to a constant tightening of obligations (and penalties) weighing on pharmaceutical companies. A more global and concerted approach is needed, particularly at European level, to reconcile the imperatives of health safety and the economic realities of the pharmaceutical sector.
Released on Dec 4, 2025
Brazilian regulatory expectations for connected medical devices
This article examines the cybersecurity and data protection requirements for connected medical devices in Brazil, integrating the Brazilian Health Regulatory Agency’s (Agência Nacional de Vigilância Sanitári or ANVISA) device safety guidance (including Guide No. 38/2020) with the General Data Protection Law’s (Lei Geral de Proteção de Dados Pessoais or LGPD) obligations when dealing with sensitive health data. The article concludes with a set of practical measures to align clinical safety, regulatory compliance and resilience during Internet of Medical Things (IoMT) and software as a medical device (SaMD) deployments.
Released on Dec 4, 2025
Natural disasters and the fragility of the right to health in Mexico
In recent weeks, heavy rains and floods affecting states in south Mexico have once again exposed the fragility of Mexico’s public health system. In the most marginalised rural communities, access to medical services is often interrupted or disappears entirely, revealing the persistent inequality that continues to characterise the country. This article reflects on the relationship between environmental vulnerability, poverty and health, and underscores the urgent need for public policies that integrate health resilience and social justice.
Released on Dec 3, 2025
Japan’s evolving AI and digital health regulations: legal developments and outlook
This article provides an overview of Japan’s evolving regulatory landscape for artificial intelligence (AI) and digital health. It highlights key developments pursuant to the Pharmaceuticals and Medical Devices Act, including initiatives such as the Digital Transformation Action Strategies in Healthcare (DASH) for software as a medical device (SaMD), as well as emerging trends in AI-driven drug discovery. The discussion also outlines Japan’s broader AI governance framework, including the AI Business Operator Guidelines and the newly enacted AI Promotion Act.
Released on Dec 3, 2025
Digital therapeutics and AI-driven health apps: regulatory and intellectual property considerations
Determining a product’s classification is arguably one of the most important steps involving its initial assessment. Whether a product is considered a medical device, an in vitro diagnostic device (IVD) or a consumer product will dictate the specific product safety and compliance legislation that applies.
Released on Dec 3, 2025
Cybersecurity and the life sciences sector: the NIS2 Directive
The European Union’s Revised Network and Information Security Directive, Directive (EU) 2022/2555 of the European Parliament and of the Council of 14 December 2022 on measures for a high common level of cybersecurity across the Union, amending Regulation (EU) No 910/2014 and Directive (EU) 2018/1972, and repealing Directive (EU) 2016/1148, otherwise known as the NIS2 Directive, forms part of a package of measures to improve the cybersecurity of critical organisations.
Released on Dec 3, 2025
Traditional food and food innovation in South America: the regulatory challenges related to identity and globalisation
This article analyses the regulatory challenges faced by Bolivia and Uruguay in regard to balancing the need to preserve traditional foods alongside the need to incorporate food innovation. Based on the concept of novel foods, the article examines how international regulations can both protect and limit access to culturally rooted products within global markets. The opportunities to harmonise food-related identities, sustainability and regulatory developments in South America within this context are also explored.
Released on Dec 3, 2025
Regulatory compliance and trends in life sciences in Paraguay
The life sciences sector in Paraguay, which includes pharmaceuticals, cosmetics, medical devices and other regulated industries, is subject to an increasingly demanding regulatory environment. Competent authorities are strengthening control mechanisms, positioning them as strategic tools to ensure regulatory compliance. In this context, private sector regulatory teams play a key role in managing complaints, anticipating risks and aligning operations with the legal requirements, while integrating robust compliance practices and internal policies. This article assesses the relevant regulatory trends, reporting mechanisms and the evolution of the in-house regulatory team as a strategic actor within the life sciences environment.
Released on Dec 3, 2025
Medical and therapeutic cannabis in Uruguay
Uruguay has strengthened its position as a regional leader in the regulation, research and therapeutic use of cannabis. Through the National Programme for Access to Medicinal and Therapeutic Cannabis, the Ministry of Public Health (MSP) promotes an integrated health approach, professional training and scientific research. Recent initiatives include educational programmes for healthcare professionals, the creation of the Cannabis Research Fund, and the establishment of the Institute for Regulation and Control of Cannabis (IRCCA) Honorary National Council. These actions reflect Uruguay’s commitment to evidence-based policy, innovation and safe patient access to cannabinoid-based treatments within a regulated public health framework.
Released on Dec 3, 2025
Digital therapeutics and AI-driven health apps: regulatory and IP considerations from a Colombian legal perspective
This article examines Colombia’s framework for digital therapeutics and artificial intelligence (AI) driven health apps, linking medical record obligations and data protection requirements to Software as a Medical Device (SaMD) workflows. It outlines the legal status of medical records, the interoperable electronic medical records (HCEI), and safeguards for automated processing, including consent and algorithm auditability. The regulatory section maps current INVIMA registrations and notes the absence of autonomous AI approvals, highlighting reliance on FDA/EU authorisations for homologation. The IP analysis addresses patentability limits for software, protection of computer implemented inventions, and complementary tools such as copyright, industrial designs, trademarks, and trade dress.
Released on Dec 3, 2025
Contractualising ESG: tools for strategic compliance in the life sciences sector
As environmental, social and governance (ESG) compliance becomes a legal imperative in the life sciences industry, contractual clauses are emerging as critical tools for implementing due diligence, mitigating supply chain risks, and meeting regulatory and investor expectations. This article examines the legal function and enforceability of ESG clauses under German law, particularly in light of the German Act on Corporate Due Diligence Obligations in Supply Chains (Lieferkettensorgfaltspflichtengesetz or LkSG) and the EU Corporate Sustainability Due Diligence Directive (CSDDD). It provides practical guidance on clause design, enforceability challenges and the strategic advantages of ESG-driven contract governance.
Released on Dec 3, 2025
Due diligence in life sciences M&A: navigating risk in complex transactions
Due diligence is a vital process within an M&A project that enables buyers to thoroughly assess a target company or group before finalising a deal. In the life sciences sector, this process is particularly complex due to the highly regulated environment and the nature of the products involved. A well-executed due diligence exercise helps identify potential liabilities, evaluate risks, confirm expectations and ensure the transaction is commercially viable.
Released on Dec 3, 2025
Trade secrets and IP protection in biotech collaborations and licensing deals
This article examines how intellectual property (IP) rights, particularly trade secrets and patents, are leveraged in biotech collaborations and licensing agreements, with a focus on the UK legal landscape. It outlines the types of assets commonly licensed, contrasts the benefits and limitations of trade secret protection versus patenting, and provides practical advice for structuring deals to safeguard innovation. The discussion is framed within the UK legal context, with implications for international participants engaging in cross-border biotech ventures.
Released on Dec 3, 2025
Decentralised clinical trials: key considerations for data management and monitoring
Decentralised clinical trials (DCTs) represent a transformative approach to clinical research, offering enhanced accessibility and efficiency while presenting novel regulatory and operational challenges. This article examines key considerations for data management and monitoring in DCTs, focusing on the distribution of responsibilities, technical prerequisites, data quality and General Data Protection Regulation (GDPR) compliance. Particular attention is given to monitoring strategies that account for reduced physical interaction between investigators and participants. The Swedish experience illustrates how national infrastructure and regulatory frameworks shape DCT implementation, highlighting opportunities for strengthening competitiveness in clinical research and jurisdiction-specific challenges, including restrictions on remote access to medical records.
Released on Dec 3, 2025
Advertising and labelling of medicinal products on social media
This article examines the regulatory landscape surrounding the advertising and promotion of prescription-only medicines on social media, with a particular focus on Ireland and on GLP-1s. It explores digital promotion and regulatory frameworks, highlighting the role of the key Irish stakeholders in monitoring and enforcing advertising compliance. It discusses recent trends in the online promotion of GLP-1s, content creators and recent steps taken by the European Medicines Agency (EMA) in this space. It also considers the implications of recent enforcement actions and the importance of robust internal policies (including for employees) to ensure compliance in the digital age.
Released on Dec 3, 2025
Poland to amend reimbursement laws again, this time for the better?
The article analyses Poland’s draft law amending the reimbursement act, aimed at reversing some of the reforms adopted in 2023. Key proposals include a new reimbursement category bridging outpatient and inpatient use, streamlined applications for prioritised products, and clarified health technology assessment (HTA) and negotiation mechanisms. The draft refines pricing through more flexible price increases and rolling post-exclusivity reductions. It narrows reimbursement secrecy, rebalances obligations concerning continuity of supply obligations, and enhances digital reporting and data access. According to the Polish government, all this is supposed to improve access to innovative medicinal products, as well as predictability and transparency of reimbursement.
Released on Dec 3, 2025
Decentralised and remote clinical trials: evolving legal framework
The rapid shift toward decentralised and remote clinical trials, accelerated by the Covid-19 pandemic, is transforming trial design and oversight. This article maps the evolving legal framework, addressing Good Clinical Practice recognition, varying European Union and United States approaches, and emerging guidance under Accelerating Clinical Trials in the EU (ACT EU) and European Medicines Agency (EMA) recommendations. It analyses core operational risks: patient safety, eConsent integrity, data protection and cross-border data transfers, cybersecurity, telemedicine compliance, investigational product delivery, and device/software classification. It seems that decentralised models can expand access and reduce costs of clinical trials, provided risk-based safeguards are embedded and national rules are aligned with international standards.
Released on Dec 3, 2025
Argentina – advertising and labelling of medical products on social media
This article analyses the Argentine legal framework applicable to the advertising and labelling of medicines and medical devices, particularly in the context of social media and digital platforms. It also explores the main compliance challenges, enforcement trends and recommendations for companies seeking to promote health-related products online.
Released on Dec 3, 2025
Medical cannabis: regulatory divergence and product liability
Regulations on medicinal cannabis in Argentina have evolved significantly over the past eight years; however, market development remains limited. This article examines the key factors influencing the current regulatory landscape, with a particular focus on medicinal use and product liability, which is essential to ensuring the safe and responsible use of cannabis.
Released on Dec 3, 2025
Artificial intelligence in drug discovery: the legal status of AI-generated inventions
The rapid development of artificial intelligence (AI) in recent years has the potential to significantly lower the entry barriers for drug development. However, as AI systems become increasingly more sophisticated, our legal frameworks must grapple with the possibility of inventions made by or using AI being patented. In the recent Thaler case, two inventions created autonomously by AI were denied patent protection. The Supreme Court in 2023 ruled that a natural person must be marked as the ‘inventor’ on a patent application, but whether the use of AI to help develop an invention precludes patentability remains a live legal issue.
Released on Dec 3, 2025
Artificial intelligence in drug discovery: legal status of AI-generated inventions
This article explores the impact of artificial intelligence (AI) on drug discovery and the legal issues surrounding AI-generated inventions. It analyses the progression of AI-driven tools, their integration into the pharmaceutical industry, and the intellectual property challenges that arise as AI systems become increasingly independent. This article highlights the need to reassess existing legal frameworks to keep pace with the evolving autonomy of AI in the drug development process.
Released on Dec 3, 2025
Voluntary assisted dying and end-of-life decision-making: a global perspective and lessons to be learnt
There are a number of ethical issues associated with end-of-life decision-making, including suicide and the rights of healthcare professionals and organisations to conscientiously object on religious grounds. The legal position on active euthanasia and passive advance care directives, being decisions concerning the withdrawal of life-sustaining treatment, varies significantly across jurisdictions. While some countries, such as Canada and Australia, have progressive frameworks permitting VAD and ACDs, others, including Singapore, India and the United Kingdom, maintain more restrictive approaches. Recent legislative developments, particularly in Australia and Canada, highlight the importance of having clear safeguards in place, capacity assessments and respect for individual autonomy during end-of-life care.
Released on Dec 3, 2025
Why ESG matters in due diligence and healthcare and life science legal transactions
Environmental, social and governance (ESG) considerations are increasingly significant in healthcare and life sciences due diligence and legal transactions. Australian and international funders now impose ESG requirements, with recent legislative changes mandating sustainability reporting for large entities. Regulatory bodies such as the Australian Securities and Investment Commission (ASIC) and the Australian Competition and Consumer Commission (ACCC) are prioritising enforcement against ‘greenwashing’, as demonstrated by landmark cases against Mercer and Vanguard for misleading ESG claims. Accurate environmental claims, robust due diligence and clear contractual obligations are essential to manage ESG risks. Businesses must ensure ongoing compliance, transparency, and staff training to avoid legal and reputational consequences in this evolving regulatory landscape.
Released on Dec 3, 2025